In the Lab

Do Supplement Manufacturers Validate their Products with Research?

Di Lewis

March 1, 2012

From the multivitamins in the cabinet to the protein powder in a workout drink, products of the dietary supplement industry are everywhere. Most people know there are looser regulations for dietary supplements, or nutraceuticals, than for drugs. But few know what goes into getting these products on the shelf.

The current rules on dietary supplements date back to 1994, when the Dietary Supplement Health and Education Act (DSHEA) was put into place. Under the DSHEA, the manufacturer has the responsibility to ensure product safety before going to market. Unless the product contains a new dietary ingredient—any ingredient not in use by 1994—the Food and Drug Administration (FDA) does not need to approve products. The FDA does regulate the claims nutraceutical companies make and can act if they make misleading claims or put out unsafe products.

A few local companies say there are businesses that give everyone a bad name by rushing poor products to the shelf to capitalize on trends. But many supplement companies do extensive testing to ensure their products work in the way they are intended.

The R&D Process
“I think there’s an ethical responsibility to do some kind of research to prove that what you designed does something useful,” says Brett West, director of Noni benefits research at Tahitian Noni. “Anyone can put a product out in three months, but it doesn’t mean it’s effective because a lot of that is based off of others’ research.”

Agel’s Noah Westerlund agrees. Agel usually takes anywhere from a year to two years to get a new product on the market. Most of that time is spent on research.

Westerlund, vice president of marketing, says the research department begins with a health problem, like joint pain. After identifying the target of the supplement, they look at the ingredient list approved by the FDA and what ingredients show promise in solving the problem. Then the research and development department goes to work testing different formulas, ultimately making sure they’re safe and effective by looking at blood absorption levels and symptom changes.

Tahitian Noni’s process is similar. The company generally goes through a three-part process: in vitro, lab research; in vivo, pre-clinical safety studies; and human clinical trials. While none of those steps are required in the United States for most products, West says it is both the responsible thing to do and required by many markets outside the country, like the European Union.

“You can turn around things as fast as a couple months if you want, but the problem we face is we’re not just bringing products to market in the United States. We operate in 60 different countries,” Westerlund says. “To be frank, getting a product on the shelf in the U.S. is not that difficult… But we don’t want to just put a product on the shelf. We want to make sure it works.”

Research and development can be an expensive process. Both men say they cannot disclose exact figures, but research is a significant part of the company’s budget. West says Tahitian Noni has spent millions of dollars on research, adding the safety testing required to sell in the European Union is extensive. Westerlund says research and development is the second-largest segment of Agel’s budget.

Doing Homework
For consumers, sorting through the various products, ingredients and health claims to find the right supplement can be daunting. Westerlund advises consumers to read product labels, look up unfamiliar ingredients and use PubMed to look up scientific studies. By doing such research, consumers can avoid wasting money on poor products.

In the early days of Tahitian Noni, the company was focused on obtaining patents. As the company has grown, West says it has seen the benefit in publishing peer-reviewed research. It gives consumers more information and helps them make smarter choices. It also separates the company from others in the crowded nutraceutical industry.

Looking for published research, both from the company and third parties, is a good way to avoid ineffective products with filler ingredients, agrees Westerlund.

West says, “There’s a lot that’s divulged in a label, especially in terms of quantities. If there are an extremely large number of ingredients, odds are there’s too little of anything to make a difference. If two dozen or 18 ingredients are listed, that indicates there’s probably too little of anything.”

Another thing smart consumers should keep an eye on is the claims on the label. Less rigorous companies sometimes don’t see the point in testing because supplement companies cannot make claims designated as drug claims, Westerlund says.